Phase 3
Completed N=169
A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1
Source: ClinicalTrials.gov NCT02170727 ↗Enrolled (actual)
169
Serious AEs
1.2%
Results posted
Aug 2019
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort — 98.6 Percentage of Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed dose combination in Genotype 1 Chronic Hepatitis C subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort |
98.6 | — |
| SECONDARY Percentage of Participants With SVR12 in the Interferon Alfa (IFN-a) Experienced Cohort |
100.0 | — |
| SECONDARY Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND |
44.2; 29.0; 87.7; 80.6; 99.3; 93.5 | — |
| SECONDARY Percentage of Participants Who Achieved HCV RNA < LLOQ TND |
11.6; 0.0; 42.0; 25.8; 93.5; 90.3 | — |
| SECONDARY Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment |
2; 0; 2; 2; 0; 0 | — |
| SECONDARY Percentage of Participants With Anemia Defined as Hb < 10 g/dL On-treatment Who Had Hb >=10 g/dL at Baseline |
1.4; 0.0 | — |
| SECONDARY Percentage of Participants Who Achieved SVR12 Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b |
88.9; 100.0; 100.0; 100.0 | — |
| SECONDARY Proportion of Participants Who Achieved SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) Status (CC Genotype or Non CC Genotype) |
99.0; 100.0; 97.4; 100.0 | — |
| SECONDARY Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12 |
100.0; 100.0; 98.4; 100.0 | — |
| SECONDARY Number of Participants With Selected Grade 3/4 Laboratory Abnormalities |
16; 5 | — |
| SECONDARY Number of Participants With/Without Cirrhosis as Measured by SAEs and Discontinuations Due to AEs |
0; 2; 1; 3 | — |
| SECONDARY Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities |
1; 6; 1; 4; 2; 2 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Subject chronically infected with HCV genotype 1 (GT-1)
- Subject without cirrhosis or with compensated cirrhosis (Child Pugh Class A)
- HCV RNA ≥ 10, 000 IU/mL at screening
- Treatment-naïve subject with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), Ribavirin (RBV), or HCV DAA (protease, polymerase inhibitor, etc.)
- Interferon (IFN) experienced subject who have received previous treatment with IFNα, with or without RBV
Exclusion Criteria
- Liver or any other transplant (including hematopoietic stem cell transplants) other than cornea and hair;
- Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening;
- Documented or suspected hepatocellular carcinoma (HCC), as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed);
- Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Data sourced from ClinicalTrials.gov (NCT02170727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.